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Pain and Industry: Challenges for Drug Development and Marketing

Pain and Industry: Challenges for Drug Development and Marketing. Douglas Y. Shapiro, MD, PhD Pfizer Global Research and Development, Ann Arbor, MI Symposium on Chronic Pain Treatment, University of Michigan, 25 May 2006. Timelines for standard drug development. Millions of

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Pain and Industry: Challenges for Drug Development and Marketing

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  1. Pain and Industry: Challenges for Drug Development and Marketing Douglas Y. Shapiro, MD, PhD Pfizer Global Research and Development, Ann Arbor, MI Symposium on Chronic Pain Treatment, University of Michigan, 25 May 2006

  2. Timelines for standard drug development Millions of Compounds Screened High Risk Process 12-15 years Preclinical Pharmacology Preclinical Safety 1 –2 Products Clinical Pharmacology & Safety Discovery Exploratory Development Full Development Phase I Phase II Phase III 0 15 10 5 Idea Drug 11 - 15 Years

  3. Ways to shorten drug development • New use for approved drug (eg Neurontin for PHN) • High probability of success, relatively fast development time • NCE with precedented mechanism of action (eg Lyrica) • Moderately high probability of success, longer development time • Benefits • Improvements over earlier compounds in PK/PD, regimen, safety, efficacy • Maintains franchise beyond initially marketed drug • Converting an unwanted side-effect into an indication • Challenges to third-party payers

  4. More ways to shorten drug development • NCE with unprecedented mechanism of action • Compound from in-licensing • Excellent source of new ideas • Shortens development time • Compound from internal source • Lower probability of success, longest development time

  5. Broad vs narrow indications • Broad indications (eg chronic pain vs chronic cancer pain) • Benefits • MDs become more familiar with how to use it • Marketing is easier, targets larger set of conditions and perhaps broader range of medical disciplines; larger market value • ? helpful for Third Party Payers • Disadvantages • MDs may need to use it differently for different indications • Harder to obtain broad indication • Might encourage MDs to try drug for unapproved uses • Narrow indications • Inverse benefits and disadvantages • Tailoring drugs to individual genotypes

  6. Industry challenges from changing regulatory definitions • NP example • Prior to 2001: 2 + 1 for broad indication • 2001 – 2005: replicate studies for narrow claim • 2006: intermediate indications possible - peripheral, central, and then general • 2 + 1 for clearly related syndromes (DPN, HIV) • 2 + 2 for less related syndromes (DPN, PHN) • Acute pain example • Compartments A, B and C • Justification: growth of knowledge • NP: requirement for nerve conduction studies • May delay NDA submissions, tend to increase the number of clinical trials

  7. Outcome Measures and marketing considerations • Ideal new pain drug • Reduces pain, minimal side-effects • Physicians prescribe it – easy to use • Insurers, HMOs pay for it • How much medical improvement needed for payers to cover prescription costs? • Need outcomes measures to assess overall economic benefit • Reduced office visits, hospitalizations, duration of stay • Introduce outcomes measures earlier in drug development • Industry partner with payers

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